RefleXion医疗放射治疗系统，Reflexion X2
K号: K252071 · 2025-12-18
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器械摘要
RefleXion Medical Radiotherapy System, Reflexion X2 is the device name listed in this FDA 510(k) record. The listed applicant is Reflexion Medical, Inc.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252071. The device is classified under product code QVA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RefleXion Medical Radiotherapy System, Reflexion X2?
RefleXion Medical Radiotherapy System, Reflexion X2 is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Reflexion Medical, Inc.. The 510(k) number is K252071.
When did RefleXion Medical Radiotherapy System, Reflexion X2 receive FDA 510(k) clearance?
RefleXion Medical Radiotherapy System, Reflexion X2 received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252071.
Who is the listed applicant for RefleXion Medical Radiotherapy System, Reflexion X2?
The FDA 510(k) record lists Reflexion Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2?
The FDA product code for RefleXion Medical Radiotherapy System, Reflexion X2 is QVA.
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列明Reflexion Medical, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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